Evidence map›Paper›PMID 26040543›Full record

Trial reportTrials2015

Evaluating rehabilitation following lumbar fusion surgery (REFS): study protocol for a randomised controlled trial.

James Greenwood, Alison McGregor, Fiona Jones, Michael Hurley

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

James GreenwoodInternal Box 8, Victor Horsely Department of Neurosurgery, National Hospital of Neurology and Neurosurgery, Queen Square, London, WC1 3BG, UK. james.greenwood@UCLH.NHS.UK.
Alison McGregorBiodynamics Lab, Imperial College London, Charing Cross Hospital, Charing Cross Campus, London, W6 8RP, UK. a.mcgregor@imperial.ac.uk.
Fiona JonesSt Georges University of London, Faculty of Health and Social Care Sciences, 2nd Floor Grosvenor Wing, Cranmer Terrace, London, SW17 0RE, UK. F.Jones@sgul.kingston.ac.uk.
Michael HurleySt Georges University of London, Faculty of Health and Social Care Sciences, 2nd Floor Grosvenor Wing, Cranmer Terrace, London, SW17 0RE, UK. Michael.hurley@sgul.kingston.ac.uk.

Funding

Department of Health CDRF-2013-04-015
6 · The paper itself

Abstract

backgroundThe rate of lumbar fusion surgery (LFS) is increasing. Clinical recovery often lags technical outcome. Approximately 40% of patients undergoing LFS rate themselves as symptomatically unchanged or worse following surgery. There is little research describing rehabilitation following LFS with no clear consensus as to what constitutes the optimum strategy. It is important to develop appropriate rehabilitation strategies to help patients manage pain and recover lost function following LFS. METHODS/

designThe study design is a randomised controlled feasibility trial exploring the feasibility of providing a complex multi-method rehabilitation intervention 3 months following LFS. The rehabilitation protocol that we have developed involves small participant groups of therapist led structured education utilising principles of cognitive behavioral therapy (CBT), progressive, individualised exercise and peer support. Participants will be randomly allocated to either usual care (UC) or the rehabilitation group (RG). We will recruit 50 subjects, planning to undergo LFS, over 30 months. Following LFS all participants will experience normal care for the first 3 months. Subsequent to a satisfactory 3 month surgical review they will commence their allocated post-operative treatment (RG or UC). Data collection will occur at baseline (pre-operatively), 3, 6 and 12 months post-operatively. Primary outcomes will include an assessment of feasibility factors (including recruitment and compliance). Secondary outcomes will evaluate the acceptability and characteristics of a limited cluster of quantitative measures including the Oswestry Disability Index (ODI) and an aggregated assessment of physical function (walking 50 yards, ascend/descend a flight of stairs). A nested qualitative study will evaluate participants' experiences. DISCUSSION: This study will evaluate the feasibility of providing complex, structured rehabilitation in small groups 3 months following technically successful LFS. We will identify strengths and weakness of the proposed protocol and the usefulness and characteristics of the planned outcome measures. This will help shape the development of rehabilitation strategies and inform future work aimed at evaluating clinical efficacy.

trial registrationISRCTN60891364, 10/07/2014.

Indexed as

Cognitive Behavioral TherapyExercise TherapyAdolescentAdultAgedBiomechanical PhenomenaClinical ProtocolsCombined Modality TherapyDisability EvaluationFeasibility StudiesFemaleHealth Knowledge, Attitudes, PracticeHumansLondonLumbar VertebraeMale

Identifiers

PMID26040543
PMCPMC4469118

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.